Abbott Vascular
Location
Jhagadia | India
Job description
Primary Function/Primary Goals/Objectives: To Sustain Quality Food Safety Assurance & Compliance of QA Operations
Major Responsibilities:
1) Customer Complaint management
u2022Responsible for implementing and maintaining effectiveness of the Quality & Food Safety Management System
u2022Coordinates the complaint investigation process for the plant in compliance with Local Regulations and Abbott policies and procedures.
To work in close coordination with Affiliate QA team on complaint investigations and resolutions
u2022Reviews batch records, complaint investigations, physical samples, and trend evaluation for inclusion of appropriate documentation in the investigation of the complaint.
u2022Notifies appropriate management (plant and division) of noted trends
u2022Assure results of the batch records and investigation information is entered accurately into the Complaint Handling Unit database within the prescribed timeframes, Customer complaint evaluation, investigation and closure in Track wise system & Coordinate with cross functional stakeholders for effective evaluation of customer complaints
2) Continuous Improvement (QA u2013 CI)
u2022Drive the Quality Culture at the site through People engagement & active Quality Campaign.
u2022Is an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.
u2022Drive all OpEx initiatives to create sustainable Continuous Improvement Culture being a Functional CI Lead.
3) CAPA Coordinator:
u2022To manage, review and support to improve of Quality of Investigations & CAPA for the Manufacturing Operation.
u2022Ensure Global Impact Assessment Review by working closely with other functional areas, identify Improvement areas, support in Implementation & execution of the Actions & share the report with divisional team.
u2022Train relevant Team members on new CAPA management tool.
u2022Support in CAPA investigations, effectiveness review during PNC / NC & critical quality issues.
To get trained on CAPA rubric and applies train the trainer concept to improve the capability of the site on CAPA methodology
Education: M. Sc / B.E / B.Tech, Biotechnology, Food Technology, Dairy Technology/Masters in relevant Field
Background: u2022 Experience : 7 to 10 years of relevant experience in Food / Pharma Industry in Manufacturing Environement.
u2022 Knowledge of Quality & Food Safety management, Documentation, Basic, Computer Knowledge, Auditing Skills, FSSC 22000, ISO 9001, FSSAI, BIS, HALAL, Regulaoty & Statutory Requirement Applicable to Food Industry
u2022 6 Sigma / Lean / Quality Circle : Black / Great Belt Project implementation
u2022 Process Innovation Skills, Decision Making Abilities
u2022 Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.
u2022 Good project management skills to deliver an effective service in a timely manner.
u2022 Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.
u2022 Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.
u2022 Able to work independently & within Multifunctional Team to deliver Organization Expectations
Accountability/Scope: u2022 Regular tracking and trending of complaints as per set procedure
u2022 Escalate abnormal trend to plant management for possible product actions as necessary, work with stakeholders for detailed evaluation of complaints and closing in system
u2022 Share complaint trend with management during monthly review meetings
u2022 Raise QR's for detail complaint investigation depending on complaint trend
u2022 Closing of complaint in Trackwise system as per defined timeline
u2022 Maintains effective communication with Corporate, Division, and Operations/QA Management
u2022 Generates reports from databases and other systems, Addresses complaint information provided by the Abbott Nutrition Complaint Handling Unit, Addresses potential high impact complaints where a potential broader issue is identified
u2022 Evaluates physical sample (field/reference), Reviews Batch Records, Coordinates and distributes investigations to the subject matter experts (SME), Maintains and tracks Plant Investigations via the site tracking system in a timely manner
u2022 Use ABTRAQ for investigations for complaints (Initiation u2013 Event Owner status), Participate in on market events and Division Complaint meetings
u2022 Complete Plant Investigation files/records, Work additional hours on rush complaints, if necessary
u2022 Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
u2022 Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance
u2022 Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
u2022 Supports the attainment of division goals and objectives.
Ensure 100% CAPA Metrics by Evaluation and progression of timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from the division's Quality System & to ensure timely closure linked to Batch Release by Working closely with Medical, Regulatory, Design Assurance and Micro team to assess the event for supporting the impact assessment and batch disposition decision.
u2022 Works closely with other functional areas with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems.
u2022 Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
u2022 Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance & Lead Site Human Reliability Program by Periodic Assessment to reduce Human Error
u2022 Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
u2022 Support in achieving Internal Audits Schedule adherence and on-time closing of Action Plans, area audits and GDP audit schedule, Supplier / Key Service Provider Audits
u2022 Compile, analyze and report CAPA metrics data for Daily Tracking, Weekly Deck, Fortnightly, Monthly & QMRM for Tier & Governance Meeting.
u2022 Ensure Training Compliance of CAPA for site & Technical Support for CAPA improvement, Ideas, Kaizens and CI Metrics for the department.
u2022 Initiate & Ensure Global Impact Assessment Review for CAPA and submit report to Division as per Global CAPA Assessment timelines.
u2022 Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner
u2022 Accountable to the Quality Organization for achieving mutually agreed upon objectives.
u2022 Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner and that viable corrective actions are identified and implemented to address any non-conformances
u2022 The CAPA System is a key inspection focus of worldwide regulators and auditors & The system must be usable, simple, sustainable and well maintained.
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